Kornimate/medical-research-clean huggingface dataset:
safety of short-term hydroxychloroquine plus azithromycin treatment in critically ill patients with severe covid-19

Conditions: COVID-19

Summary: hydroxychloroquine and azithromycin have been proposed as treatment of covid-19 patients, but few reports have assessed this combination therapy in critically ill covid-19 patients. many raised concerns regarding the potential cardiac toxicity of this association. the purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in icu for severe covid-19 with respiratory failure. the main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.


Eligibility criteria:
inclusion criteria: * critically ill patients admitted in icu for severe covid-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin. exclusion criteria: * cardiac conduction disorders * continuous anti-arrhythmic therapy * heart failure * chronic renal failure

Keywords: hydroxychloroquine adrs azithromycine torsade de pointe
wolf 24 f vs. storz 28 f laser sheath size for holep

Conditions: Benign Prostatic Hypertrophy

Summary: the purpose of this study is to compare two different types of scopes that can be used for holep. holep is performed through the urethra using a laser scope to remove obstructing prostate tissue. laser scopes come in different sizes (diameters).


Eligibility criteria:
inclusion criteria: * patients males 18-89 undergoing holep for the treatment of bothersome lower urinary tract symptoms exclusion criteria: * patients who lack decisional capacity
multisite feeding study: home surveillance and feeding strategies in infants with complex single ventricle

Conditions: Congenital Disorders

Summary: this study will assess 75-100 patients for feeding issues following surgery for single ventricle.

we wish to consent 75-100 subjects at children's healthcare of atlanta. if subjects take part in this study, the following will happen: 1. prior to discharge, the parent/guardian will be given a home feeding log and 2. parents will bring the feeding log to regularly scheduled clinic visits. clinic staff will also weigh the child and measure head circumference at each clinic visit. 3. the investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications. 4. the parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. they will be asked to fill out the same questionnaire 3 times: * first time will be before they leave the hospital after the baby's surgery, while still a patient on the cardiac step down unit (csu). * second time will be at the sibley heart center cardiology clinic after they have been home for approximately 4 weeks. * third time will be at the sibley heart center cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery. it should take about 15 minutes to fill out the questionnaire. the questionnaire is the only research procedure. the data from the feeding log and clinic visits will be submitted to cincinnati children's, the primary site for this study.

Eligibility criteria:
inclusion criteria: * single ventricle patients who have received the norwood stage i operation. exclusion criteria: * infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis \[nec\] or other gastrointestinal \[gi\] anomalies) * prematurity less than 37 weeks * infants greater than 30 days of age at stage i palliation * parents who cannot read or understand questionnaires administered as a part of the study.

Keywords: congenital heart disease single ventricle infant feeding
impact of endothelial cell activation and modifications of haemostasis induced by infective endocarditis on the risk of embolism

Conditions: Infective Endocarditis

Summary: prospective study including all the consecutive patients admitted at the department of cardiology, timone hospital wih a definite diagnosis of ie according to the modified duke criteria. the period of inclusion will be for 24 months. eighty patients and age-matched control subject will be included. primary end point are ee occurring during the antimicrobial treatment and secondary end points will be 6-month mortality, vegetation length and the impact of antimicrobial treatment on inflammation-induced procoagulant changes and endothelial cell activation.


Eligibility criteria:
inclusion criteria: * all the patients presenting certain diagnosis of infectious endocardite according to the criteria of modified duke exclusion criteria: * age \< 18 years * pregnancy and feeding * health not allowing to give the assent * innate abnormalities of the haemostasis * more than a week before the inclu antibiothérapie adapted begun
vivigen cellular bone matrix for hindfoot or ankle arthrodesis

Conditions: Ankle Deformity; Ankle Arthritis

Summary: to evaluate the fusion status of the hindfoot bones after receiving the vivigen graft, an fda approved cellular bone matrix. this is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.


Eligibility criteria:
inclusion criteria: * patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure * age 18-80 * willing to complete all follow up evaluations exclusion criteria: * prior infection at site of planned arthrodesis * prior arthrodesis procedure * inability to maintain non-weight bearing status * bone defect requiring more than 10 cc of bone graft material * known vitamin d deficiency with a vitamin d level of \<30ng/ml 1 week prior to surgery * inadequate bone stock to allow for rigid internal fixation * hemoglobin a1c greater than 8.0% * tobacco or nicotine use 6 weeks prior to surgery * bmi greater than 40

Keywords: arthrodesis
the effect of microfracture procedure on rotator cuff tendon healing

Conditions: Rotator Cuff Tears; Micro Fracture

Summary: patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. one group of patient will undergo standard arthroscopic rotator cuff repair, while the other group will have microfracture procedure in addition to the standard arthroscopic repair. before the operation, functional and clinical conditions will be recorded with constant and american shoulder and elbow surgeons shoulder score (ases) universal shoulder scoring systems and visual analogue scale(vas) pain scale. the blood supply and healing of the tendon in the repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the 2nd, 4th, 8th and 12th week after the operation. post-operative clinical, functional status and pain levels will be evaluated with constant, ases and vas pain scales at 24th week.


Eligibility criteria:
inclusion criteria: * degenerative rotator cuff tears exclusion criteria: * traumatic rotator cuff tears * rheumatoid diseases * previous surgery of rotator cuff tendon * glenohumeral arthritis * acromioclavicular arthritis

Keywords: superb microvascular imaging rotator cuff tears micro fracture
methylprednisolone injections treating birch pollen induced allergic rhinitis.

Conditions: Rhinitis, Allergic, Seasonal; Hay Fever; Pollen Allergy; Allergic Rhinitis

Summary: this study evaluates the effect of intramuscular injected methylprednisolone treating birch pollen induced rhinitis compared to placebo.

the study was an interventional single center double-blinded human randomized trial with two groups treated parallel.the first group received an intramuscular injection of methylprednisolone 40 mg/ml 2ml x 1 as a single dose. the second group received an intramuscular injection of nacl 0,9 mg/ml 2ml x 1 as a single dose. symptom score and the use of medication was registered daily during the pollen peak of the season, using an electronic diary. the study was conducted during the spring of 2019.

Eligibility criteria:
inclusion criteria: * severe birch pollen induced allergic rhinitis. * signed informed consent according to international council of harmonisation/good clinical practice, and national/local regulations. * women of considered childbearing potential (wocbp) will only be included after a negative highly sensitive pregnancy test according to ctfg recommendations. exclusion criteria: * pregnancy or nursing. * autoimmune or collagen disease. * cardiovascular disease. * hepatic disease. * renal disease. * cancer. * upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive- and restrictive lung disease). * medication with a possible side-effect of interfering with the immune response. * previous immuno- or chemotherapy. * chronic disease. * major metabolic disease. * alcohol or drug abuse. * mental incapability of coping with the study. * known or suspected allergy to the study product. * suspicion of or confirmed bacterial infection. * known allergy to the study drugs, "rescue medication".
effects of telerehabilitation exercise program on maternal glycemic control

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. it appears in week between 24 to 28 and and raises the mothers and childs risk of problems. it is thought to affect about 1 in 7 pregnancies worldwide. through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.the results will help clarify how telehealth intervention can best support gdm patient's maternal health outcomes.

literature suggests that hormonal changes during pregnancy can interfere with insulin, the hormone that regulates blood glucose.this excess glucose can cross the placenta, affecting the developing fetus and increasing risks for both mother and child. the rising trends in obesity and advanced maternal age suggest that the prevalence of gdm will continue to increase.approximately 7-10% of pregnancies worldwide are affected by gestational diabetes.managing glucose levels is critical for women with gestational diabetes to ensure a healthy pregnancy and reduce the risk of complications for both mother and baby. developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. the use of telerehabilitation may improve blood glucose levels in participants with gdm. the control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. the results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with gdm in improving maternal blood glucose level.

Eligibility criteria:
inclusion criteria: * women aged 20 to 35 years * gestational age between 20-28weeks * diagnosed with gestational diabetes mellitus through oral glucose tolerance test (ogtt) * primigravida and multigravida * able to do 6 6-minute walk tests under a severity level of 6 on the borg scale of breathlessness. * patients or caregivers have and able to use an electronic device (pc, tablet or smartphone) * who signed informed consent exclusion criteria: * previously diagnosed t1dm or t2dm * high-risk pregnancy conditions contraindicating exercise as per acog guidelines * patients taking insulin regularly. * patients with fetal anomalies diagnosed at 20 th week. * multiple gestation (twin or triplets)
hearttrends hrv algorithm for the detection of myocardial ischemia

Conditions: Heart Rate Variability Ischemia Detection

Summary: a total of 621 consecutive male and female subjects, without established cad, referred to exercise stress testing (est) due to 1) chest pain syndromes or equivocal/equivalent angina with intermediate pretest probability for cad; 2) , or asymptomatic subjects with diabetes mellitus who are referred est for risk assessment prior to initiation of an exercise program. to validate the diagnostic performance of the hearttrends device for the detection and ruling out of myocardial ischemia in a population of subjects who are currently referred for cardiovascular evaluation using est. prospective multicenter single-armed study, assessing the diagnostic accuracy of hrv analysis by the hearttrends device for the detection of myocardial ischemia, as determined by stress echocardiography.


Eligibility criteria:
inclusion criteria: * age ≥ 21 * no known cad * referral for est due to either one of the following two indications: 1. chest pain syndrome or equivocal angina in subjects with intermediate pretest probability of cad according to the 2002 updated guidelines for exercise stress examination.1 (see definition of intermediate pretest probability of cad in supplementary appendix table at the end of this document); or 2. asymptomatic subjects with diabetes mellitus referred to est for risk assessment prior to initiation of an exercise program. * willing and able to provide written informed consent exclusion criteria: 1. acute coronary syndrome 2. established cad 3. atrial fibrillation or flutter 4. cardiac pacemaker 5. clinical diagnosis of heart failure 6. severe copd (fev1\< 50% predicted value) 7. active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis 8. known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate; 9. any illness that might reduce life expectancy to less than 1 year from screening 10. left bundle branch block (lbbb), significant intra-ventricular conduction delay (ivcd) or significant (\>1mm) st deviations on baseline ecg 11. inability to perform an exercise stress test (i.e. orthopedical or neurological limitations) 12. any significant valvular disease defined as: established valvular regurgitation or stenosis abnormality above moderate severity 13. bmi \>35 kg/m2 14. recent (\< 6 months) history of pulmonary embolism -
effects of atorvastatin versus pravastatin on platelet inhibition by clopidogrel

Conditions: Ischemic Heart Disease; Acute Coronary Syndromes

Summary: clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (adp)-induced platelets aggregation is attenuated by co-administration of certain statins. the objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary syndrome after percutaneous coronary intervention (pci). in this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. all patients will be followed up for one year. the primary endpoints include death, non fatal ami, urgent revascularization. the secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.


Eligibility criteria:
inclusion criteria: * diagnosed with acs. * between ages of 18 years and 85 years. * presence of one or several stenosis in native coronary arteries requiring pci. * willing and able to sign informed consent. exclusion criteria: * a history of bleeding diathesis. * new york heart association functional class iv. * prior pci or coronary bypass grafting \< 3 months. * contraindications to statins, clopidogrel and aspirin (white blood cells counts \< 4×109/l or platelet counts \<100 g/l; creatinine clearance \<25 ml/ min; active liver disease). * use of glycoprotein iib/iiia inhibitors before pci. * use of statins before pci.

Keywords: ischemic heart disease acute coronary syndromes percutaneous transluminal coronary angioplasty statin clopidogrel
shapeup empower study

Conditions: Obesity; Overweight

Summary: this randomized controlled trial will evaluate patterns of use and health outcomes of the shapeup empower online program with and without financial incentives for program engagement.


Eligibility criteria:
inclusion criteria: * age 18-70 years * body mass index (bmi) between 25 and 45 kg/m2 * english speaking * have access to the internet via a computer and smartphone compatible with empower and commercial apps, and basic knowledge of how to use this technology. * agree to sharing of data entered in the empower and commercial apps intervention systems. * agree to shapeup's privacy policy and user agreement. exclusion criteria: * report health problems that make weight loss or unsupervised exercise unsafe or unreasonable * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire * are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months * are planning to move outside of the greater providence area within the next 12 months * report any cognitive or physical limitations that preclude use of a personal computer * have participated in a study conducted by the wcdrc in the past 2 years * have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program * weight loss of ≥ 5% of initial body weight in the last 6 months * history of clinically diagnosed eating disorder excluding binge eating disorder. * previous surgical procedure for weight loss * currently taking weight loss medication\\ * treatment of cancer within the last 6 months * have any medical or psychological condition, or life situation, that would make participation in a weight loss program inadvisable in the opinion of the principal investigator.
surface stimulation for female sexual dysfunction

Conditions: Female Sexual Dysfunction

Summary: female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the united states alone. peripheral nerve stimulation, such as posterior tibial nerve stimulation (ptns) and dorsal genital nerve stimulation (dgns) can modulate neural circuits for bladder and fecal continence. the investigators hypothesize that periodic dgns and ptns will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. subjects will be randomized to receive one of the stimulation approaches. subjects will have weekly 30-minute sessions across twelve weeks.


Eligibility criteria:
inclusion criteria: * adult women ≥ 18 years of age * sexually active ≥ 1 time per month (≥ 2 times per month preferred) * score of 19 or less on a 6-question set of the female sexual function index (fsfi) survey * neurologically stable * ambulatory * capable of giving informed consent * english speaking * capable and willing to follow study procedures exclusion criteria: * men * women ≤ 17 years of age * pregnant or planning to get pregnant during the study period * clinically diagnosed neurological bladder dysfunction * prior experience with ptns or dgns * current use of transcutaneous electrical nerve stimulation (tens) on pelvis, back, or legs * implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator * taking flibanserin * taking any investigational drug * history of neurologic diseases or impairments * any other factors that the investigators feel would place the patient at increased risk from this study

Keywords: hypoactive desire disorder female sexual dysfunction genital arousal disorder sexual dysfunction female arousal electrical stimulation transcutaneous electrical stimulation women
a pilot clinical investigation of the efficacy and safety of uracyst® versus placebo in patients with interstitial cystitis/painful bladder syndrome.

Conditions: Interstitial Cystitis

Summary: this is a pilot clinical investigation. patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.


Eligibility criteria:
inclusion criteria: * are female of male patient 18 years or older * have been previously diagnosed with ic/pbs. * are willing to provide informed consent * available for the duration of the study including treatment and follow-up (12 weeks) exclusion criteria: * pregnant or lactating female. * are currently or have previously received investigational drugs within thirty (30) days of screening. * previous therapy for ic/pbs * have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results. * are unable or unwilling to comply with protocol requirements * are unable to read, understand, and provide written informed consent.

Keywords: ic/pbs interstitial cystitis/painful bladder syndrome
do epidurals placed at a lower level improve labor analgesia?

Conditions: Labor Analgesia

Summary: the investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.


Eligibility criteria:
inclusion criteria: * women in active labor exclusion criteria: * known contraindications to epidural analgesia * moderate to severe systemic illness as evidenced by an american society of anesthesiologists (asa) score of 3 or higher. * known abnormalities of the spinal column * any neurologic illness * multiple gestations, fetal abnormalities or fetal presentation other than vertex * recent history of analgesic usage * an inability to communicate in english or french * body mass index greater than 40 * patients in pain requesting an immediate epidural

Keywords: epidural labour analgesia
phase 3 study of khk7580

Conditions: Secondary Hyperparathyroidism

Summary: this study is designed to evaluate efficacy and safety of khk7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. after 32-week treatment period, the subjects will receive khk7580 in the 20-week extension period to evaluate long-term safety and efficacy.


Eligibility criteria:
inclusion criteria: * personally submitted written voluntary informed consent to participate in the study * stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening * intact pth level of \> 240 pg/ml at screening exclusion criteria: * treatment with cinacalcet hydrochloride within 2 weeks before screening; * change in dose or dosing regimen of an activated vitamin d drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; * parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; * severe heart disease; * severe hepatic dysfunction; * uncontrolled hypertension and/or diabetes; * treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; * primary hyperparathyroidism; * other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.